Kornimate/medical-research-clean huggingface dataset:
wounds protocol at family health strategy units in a rio grande do sul countryside town

Conditions: Chronic Vascular Wounds in Adults

Summary: evaluate the process for implementing a wound protocol for lesion control and cost-effectiveness in the context of the family health strategy in the city of santa cruz do sul, brazil.


Eligibility criteria:
inclusion criteria: * presenting vascular (venous, arterial or mixed) ulcers for over 1 year; * be available to have wounds dressed at the healthcare unit; * be a patient registered with the family health strategy teams. exclusion criteria: * have some condition rendering the patient unable to go to the unit, such as being bedridden or having had a lower limb amputated; * having decompensated diabetes mellitus; * having move away from the family health strategy unit's coverage area.

Keywords: nursing care skin lesions wound healing varicose ulcers
immediate and long-term induction of incretin release by artificial sweeteners 2

Conditions: Diabetes; Pre-diabetes

Summary: epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes. recent studies in animals and humans have shown, that artificial sweeteners (as) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release. data on human subjects are sparse and controversial, especially in a long-term manner. we therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.

epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes. recent studies in animals and humans have shown, that artificial sweeteners (as) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release. data on human subjects are sparse and controversial, especially in a long-term manner. we therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. metabolic assessment will be based on oral glucose tolerance tests.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Keywords: incretin release
continuous paravertebral block on postoperative pain after hepatectomy

Conditions: Right Lobe Hepatectomy

Summary: patients often experience moderate to severe postoperative pain, especially during the first hours after hepatectomy. systemic opioids given with patient-controlled analgesia has be used after hepatectomy in many medical center(aubrun, monsel et al. 2001; aubrun, salvi et al. 2005), but the analgesic effect can be limited and undesirable side effects may occur. a case report described that right thoracic paravertebral block reduced pain and analgesic requirements after right lobe hepatectomy(ho, karmakar et al. 2004). compared with epidural analgesia, thoracic paravertebral block probably carries a much lower risk of spinal haematoma in the presence of moderate haemostatic deficiencies (richardson and lonnqvist 1998; karmakar 2001). we therefore designed a prospective, randomized, subject and assessor blinded, parallel-group, placebo controlled study to test the hypothesis that continuous right thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (pca) with sufentanil.


Eligibility criteria:
inclusion criteria: * age 18-70 yrs * american society of anesthesiologists physical statusⅰ-ⅲ * undergo right lobe hepatectomy * informed consent exclusion criteria: * a known allergy to the drugs being used * coagulopathy, on anticoagulants * analgesics intake, history of substance abuse * participating in the investigation of another experimental agent * inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)

Keywords: thoracic paravertebral block postoperative pain right lobe hepatectomy patient controlled analgesia
buprenorphine detoxification - bbdvi - 19

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to examine the long-term efficacy of alternate-day dosing schedules in promoting treatment compliance in the absence of confounding behavioral contingencies.


Eligibility criteria:
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combined intrathecal morphine and dexmedetomidine analgesia

Conditions: Postoperative Pain

Summary: the current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.

opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.the human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. in this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (group i/bupivacaine group), bupivacaine and 0.5 mg morphine (group ii/morphine group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (group iii/morphine-dex group). the assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.

Eligibility criteria:
inclusion criteria: - major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy) exclusion criteria: * known allergy to study drugs * significant cardiac, respiratory, renal or hepatic disease. * 2nd or 3rd degree heart block. * coagulation disorders. * low back pain or other back problems. * drug or alcohol abuse. * bmi\>30kg\\m2. * psychiatric illnesses that would interfere with perception and assessment of pain.

Keywords: analgesia intrathecal opioids morphine dexmedetomidine
a brief appetite awareness intervention for eating and weight regulation among college freshmen

Conditions: Obesity; Eating Disorders

Summary: the proposed study is a randomized clinical trial investigating the effects of a weight gain and eating dysregulation prevention intervention among college freshmen women. it will compare appetite awareness training (aat) to a standard nutritional education group and a no treatment control group. appetite awareness training approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues.

all female freshmen students residing in the university dorms were recruited to participate in this study. after completing the baseline assessment, eligible participants were randomly assigned to one of the three arms. those in the aat condition received guided administration of aat over the course of three weekly group sessions, with an additional booster session three weeks after completion (week 6). the standard treatment comparison group received four similarly timed group sessions of psychoeducational/nutrition information facilitated by a registered dietician. a manualized approach to administration of the intervention was created based on the aat treatment and was strictly followed in order to standardize the implementation of the prevention groups. the no-treatment control group only participated in the assessments.

Eligibility criteria:
inclusion criteria: * incoming university of minnesota duluth freshmen women residing in on campus dormitories exclusion criteria: * males, non-dormitory residing, non-freshmen.

Keywords: obesity eating disorders appetite regulation eating regulation
supplementation with vitamin d to patients with heart failure (d-heart).

Conditions: Heart Failure With Reduced Ejection Fraction; Vitamin D Deficiency

Summary: in 200 patients with documented systolic heart failure give supplementation with vitamin d in those with a 25-oh- vitamin d \< 50nmol/l - or placebo. in those with a vitamin d level \<25nmol/l a substitution of 2400iu will be given, and in those with a vitamin d level 25-50nmol/l a substitution of 1600iu will be given. intervention time 12 months. biomarkers of heart function, quality of life, and hospitalisation will be analysed.

in a population with a systolic heart failure with an ef\<40%, the levels of vitamin d will be analysed. in those with a 25-oh-vitamin d level \<50nmol/l the patients that accept participation, will be randomised into active supplementation as described below, or placebo. * in those with a 25-oh-vitamin d level \<25nmol/l there will be a supplementation of 2400iu daily * in those with a vitamin d level 25-50nmol/l there will be a supplementation of 1600iu daily, * or placebo. thus based on the basal level of vitamin d the screened patients will either be excluded due to high level of vitamin d, or given one ot the two options of vitamin d dosage based on the basal patient level - or placebo. the intervention time will be 12 months. in the project 200 heart failure patients will be included. blood samples including heart failure biomarkers, and biomarkers for inflammation and oxidative stress will be drawn at 3,6, 9 and 12 months. health related quality of life will be evaluated by use of euro-qol-5d minnesota living with heart failure.patient health questionnaire-9 multidimensional fatigue inventory 20 questionnaire, as also hospitalisation during the project time. cardiac function according to echocardiography will be analysed at start, and study end.

Eligibility criteria:
inclusion criteria: * patients with documented and stable systolic heart failure and connected to an outpatient clinic at the dept of cardiology in linköping, or jönköping, sweden, and with a 25-oh-vitamin d \<50nmol/l exclusion criteria: * patients with unstable heart failure * patients with significant valvular disease, or ischemic heart disease planned for operation * patients with significant renal or /and liver impairment. * patients that do not understand that study information, or that are not willing to participate
transcutaneous non-invasive stimulation of the vagus nerve for the treatment of difficult-to-treat epilepsy

Conditions: Epilepsy

Summary: the aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.


Eligibility criteria:
inclusion criteria: * written informed consent * patients of both gender, aged from 18-75 years * diagnosis of epilepsy according to the diagnosis criteria of the dsm iv/ icd 10 (especially g 40.1 /g 40.2/ g 40.3) * insufficient response to at least one attempt of treatment in medical history with anticonvulsive medication, dosed sufficiently long and high * antiepileptic drugs (aed) therapy must be stable at a level that promises long-term continuity for at least 10 before study start and has to be continued for at least 3 months during treatment phase exclusion criteria: * absence of informed consent * pregnancy * psychiatric diseases, especially post-traumatic stress disorder, obsessive-compulsive disorders, schizophrenia, borderline personality disorders (bpd), character disorders as well as major depressive disorders, anxiety disorders and eating disorders as comorbidity. * abuse of drugs and alcohol until 12 weeks before study start * cerebrovascular diseases * dementia * severe traumatic brain injury in medical history including invasive and non-invasive methods of therapy (tumor surgery, "gamma knife surgery") * indications of structural impairment of the basal ganglia or the brain stem * active implants (e.g. cochlea implants, vns, pacemaker) * severe neurological diseases (e.g. morbus parkinson, systemic neurologic diseases * severe internistic diseases (e.g. arterial hypertension, respiratory failure) * bronchial asthma * malignant diseases of any kind, within five years before study start * severe active infectious diseases (e.g. hiv, hepatitis) * bone diseases (e.g. morbus paget, recent fractures) * diseases of the ent body system: hearing loss of the left ear which is treated with a hearing instrument, all dermatologic and infectious diseases which affect the area around the pinna and the ear canal, severe malformation of the pinna * vagotomy * concurrent participation in other studies * other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject

Keywords: seizure disorder, seizures, convulsions, grand mal, petit mal, absence seizures, repeated seizures, children's seizures, secondary epilepsy, symptomatic epilepsy, generalized seizures, partial seizure, focal seizure, partial complex seizure, anticonvulsant medication
exploring folk health practices in latinos with chronic medical conditions

Conditions: Diabetes; Hypertension; Asthma; Heart Disease; Stroke; Arthritis

Summary: this study will explore how culture influences the use of folk healing practices and medical services in latinos with chronic medical conditions.

sociocultural aspects of using ethnomedical health practices in a community-based latino population will be described using both qualitative and quantitative survey methods. this study will rely heavily on its descriptive section, which will use in-depth, open-ended questions in a semi-structured personal interview format following qualitative research principles. it will also use closed-ended questions in a short survey format to begin to explore some variables that may be associated with using traditional healing practices. these variables include level of acculturation, degree of family social support, degree of adherence to standard medical regimens, perceived health status, presence of depressive symptoms, and severity of co-illnesses. these variables will be examined using common, validated scales.

Eligibility criteria:
inclusion criteria: participants will be self-identified, adult men and women from the community setting. the sample comprise a convenience sample, including persons of mexican, puerto rican, cuban, dominican, central american, south american, or other spanish speaking culture. 1. latino men and women over the age of 18 2. those self-identifying as having at least one chronic medical condition including:diabetes, hypertension, asthma, history of heart disease or stroke or musculoskeletal disease (arthritis). 3. those reporting use of complementary or alternative therapies, including ethnomedical healing practices or practitioners. 4. those who speak english or spanish. exclusion criteria: individuals who refuse to participate.

Keywords: latino patients health practices culture influences
bilateral, masked comparison of peg-400 based artificial tear and systane for the treatment of dry eye signs, symptoms and visual quality

Conditions: Dry Eye

Summary: to evaluate and compare the effects of peg-400 based artificial tear and systane tears in mild-moderate dry eye patients. tbut, visual impact and subjective evaluations will be assessed in this month long trial.


Eligibility criteria:
inclusion criteria: * patient reported dry eye symptoms (episodic, annoying, activity limiting), ses od. * physician assessment of mild-moderate dry eye * patient willing to instill drops qid and complete entire length of protocol. * tbut \< 10 seconds * bcva of 20/30 or better exclusion criteria: * current topical cyclosporine use (restasis) * current systane use * refractive surgery within the last 6 months * oral or topical corticosteroid use * severe dry eye patients by physician assessment * current active blepharitis * oral doxycyclines use * oral antihistamine use
validation of the utility of an intelligent visual acuity diagnostic system for children

Conditions: Ophthalmopathy; Artificial Intelligence

Summary: visual development during early childhood is a vital process. examining the visual acuity of children is essential for the early detection of visual abnormality, but performing such an assessment in children is challenging. here, the investigators developed a human-in-the-loop artificial intelligence (ai) paradigm that combines traditional vision examination and ai with integrated software and hardware, thus making the vision examination easy to perform. the investigator also establish a entity intelligent visual acuity diagnostic system based on the paradigm, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.


Eligibility criteria:
inclusion criteria: * paediatric patients from eye clinic written informed consents provided

Keywords: vision disorders
study to evaluate the effectiveness of drg stimulation for discogenic low back pain

Conditions: Chronic Pain

Summary: the purpose of this prospective post market observational pilot study is to evaluate the effect of drg stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for drg stimulation as routinely utilised in the study centre. results from this pilot study will inform current clinical practice and future comparative studies in this specific population.


Eligibility criteria:
inclusion criteria: 1. subject of either gender between 18 and 65 years of age 2. subject is able and willing to comply with the follow-up schedule and protocol 3. subject is able to provide written informed consent 4. chronic low back pain of at least 6 months 5. history consistent with discogenic low back pain (e.g. pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance) 6. neurologic exam without marked motor deficit. 7. definite/highly probable/discogenic pain as confirmed by provocative discography according to iasp/isis guidelines\* 8. low back pain intensity should be 6 or higher measured on a nprs at baseline 9. meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre 10. subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study 2. escalating or changing pain condition within the past month as evidenced by investigator examination 3. bmi ≥35 4. subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months 5. subject currently has an active implantable device including icd, pacemaker, spinal cord stimulator or intrathecal drug pump 6. subject is unable to operate the device 7. severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs or ct/mri. 8. extruded or sequestered herniated nucleus pulposus at the affected level(s). 9. previous lumbar back surgery (e.g. laminectomy, discectomy or fusion) at the affected level(s) 10. moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by mri or ct in the previous 6 months 11. moderate to severe endplate degenerative changes at the affected levels 12. grade 1-2 spondylolisthesis 13. previous neurostimulation therapy

Keywords: chronic low back pain dorsal root ganglion neurostimulator system spinal cord stimulation
hypopnea and apnea detection and treatment performance of a new cardiorespiratory holter monitor

Conditions: Sleep Apnea, Obstructive

Summary: the hypnos study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. the system is known as the pasithea system and it will perform the following tasks: * detect apneas and hypopneas in real time, based on physiological signals acquired with a cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (sao2)) * upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of mechanoreceptors of the skin close to the mastoid bone the primary objective is to verify that the pasithea system is able to detect apneas and hypopneas reliably. the main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders. another objective of the study is to verify the safety of the pasithea system.


Eligibility criteria:
inclusion criteria: * above 18 years. * patient with diagnosed severe obstructive sleep apnea syndrome (ahi \> 30/h and \> 80% of obstructive events diagnosed on polysomnography or polygraphy performed less than 6 months ago ) * patient free from cpap treatment or any other sas treatment for at least 3 months * patient with stable psychotropic medication since the diagnostic polysomnography or polygraphy exam * patient has signed the informed consent exclusion criteria: * patients sleeping less than 4 hours per night * patients suffering from respiratory failure or periodic breathing (cheynes stokes) * obese patient (bmi\>40kg/m2) * diabetic patient with autonomic dysfunction * vulnerable patient in accordance with article l1121-6 of csp * patient with progressive malignant pathology * patient already involved in another clinical study that could affect the result of this study * pregnant patient
vaxchora pediatric study to assess safety and immunogenicity

Conditions: Cholera (Disorder)

Summary: vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by vibrio cholerae serogroup o1. vaxchora is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. the primary goals of this phase 4 study are to evaluate the safety and immunogenicity of a single dose of vaxchora (1 x 10e9 cfu/dose) in children ages 2 years to \<18 years of age in developed countries.

this is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.

Eligibility criteria:
inclusion criteria: * male or female * between 2 and \<18 years of age on day 1 * in general good health * able and willing to provide informed assent for study participation * primary caregiver is able and willing to provide informed consent for study participation * (for females of childbearing potential) using an acceptable method of contraception through day 29 exclusion criteria: * current acute gastrointestinal illness or loose stools within 3 days of day 1 visit * current acute febrile illness * history of cholera infection * history of cholera vaccination * history of severe allergic reaction (e.g. anaphylaxis) to any ingredient of vaxchora * congenital or acquired immunodeficiency * pregnancy (for females of childbearing potential) * any other condition that, in the opinion of the investigator, creates an unacceptable risk to the subject * any other condition that, in the opinion of the investigator, will interfere with the conduct of the study or the validity of the data * duration of \>2 weeks of abnormal stool pattern, defined as \ 2 stools per day in the past 6 months * regular use of laxatives in the past 6 months * history of enterotoxigenic e. coli infection * travel to cholera-endemic area in the previous 5 years * nursing/breastfeeding * received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: any other licensed vaccines, antibiotics, or chloroquine * received or plans to receive any other investigational agent throughout the main study (day 181)